GMP Inspection by BPOM Indonesia at PT Kalbio Global Medika
On 10-12 Aug 2022, PT Kalbio Global Medika (KGM) was inspected for Good Manufacturing Practices (GMP) by The National Agency of Drug and Food Control (NA-DFC) of Indonesia (BPOM Indonesia). This inspection was performed to fulfill Indonesian NA-DFC (BPOM Indonesia) program to have deep understanding in compliance of GMP regulations of pharmaceutical industries in Indonesia.
The scope of GMP inspection was Erythropoietin manufacturing facility, Efepoetin alfa manufacturing facility, and Non-betalactam small volume injection manufacturing facility. During inspection, there were onsite facility tour, including but not limited to warehouse, utility area, QC area, production area, and other supporting area, documentations review, discussions.
KGM at a Glance
Kalbio Global Medika (KGM) is one of the first and the pioneer of biopharmaceuticals in Indonesia, established in 2014 and inaugurated officially in 2018 by the President of the Republic of Indonesia, Ir. Joko Widodo. KGM is part of the Kalbe Group, a subsidiary of PT Kalbe Genexine Biologics (KGbio), which is a clinical-stage biotechnology company focused on bringing biologics medical innovation to markets outside US/Canada, Western Europe, and China. KGM is an Innovative CDMO, equipped with CMC and scale-up capabilities plugged into Boston biotech ecosystem and state-of-the-art facility to enhance efficiency and productivity. With API manufacturing, formulation, fill and finish capabilities of biosimilar and novel biologics, averaging 10 million units of syringes, cartridges, and vials, KGM supplies local and international markets.